Windstone Medical Head Pack Recalled for Potential Sterility Compromise
Windstone Medical Packaging recalled 40 Head Pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect (splits or holes) compromises sterility, creating a risk of infection or harm. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 40 kits of the Head Pack, part number PSS1934(B. The recall is due to a potential defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits. The gloves may contain splits or holes that could compromise sterility.
The affected products were distributed in Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia, and Washington. The specific lot numbers and expiration dates for the affected units are 87600 (8/30/2018), 87943 (11/21/2018), and 89456 (12/29/2018).
Healthcare facilities and consumers should stop using the affected Head Packs immediately. Users should check their inventory for the specific part number and lot numbers listed above. If the product matches the description, it should be returned to the supplier or the manufacturer for disposal or credit.
The recalled product
- Product
- Head Pack, part number PSS1934(B
- Manufacturer
- Windstone Medical Packaging, Inc.
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot number and expiration date 87600
- 8/30/2018 87943
- 11/21/2018 89456
- 12/29/2018
Distribution
Part of a larger recall action
This product is one of 124 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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